(168 days)
The Nipro® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set is intended for use during hernodialysis to provide access to a patient's blood. When used in hemodialysis, they are part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions.
The Nipro® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set that we intend to market includes the following three components: a Nipro® Arterial and Venous Blood Tubing Set for Hemodialysis; a Nipro® Disposable Solution Set ; and, a transducer/ protector. These devices are packaged together for convenient use during hemodialysis procedures. The Arterial and Venous Blood Tubing Sets that we intend to include within the kits include various models of blood tubing sets are available for application with different dialysis machines. A series of 27 arterial line models (A001 - A021, A026, A029 -A032, and A035) and a series of 14 venous line models (V600 - V607, V609 - V613, and V616) have been described. The Disposable Solution Infusion Set that we intend to include in the kit will be one of the 4 types of designs: NNC-3L, NNC-3CL. NNC-3C. and NNC-3CS. A transducer/protector is also included in the kit. The materials used for the components of the blood tubing sets include polyethylene (PE), polyvinylchloride (PVC), acrylonitrate butadiene styrene (ABS), polyoxymethylene (POM), polypropylene (PP), polyethylene high density (PEHD), and polycarbonate (PC). The materials used for the disposable solution infusion set include polyethylene (PE), polyvinylchloride (PVC), polypropylene (PP), and acrylonitrate butadiene styrene (ABS). The transducer/protector component of this kit is fabricated from either rigid PVC and a 0.2 micron Gore membrane (PTFE and polypropylene) or rigid PVC and PTFE and polyester.
The provided text describes a 510(k) submission for a medical device (Nipro® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set) seeking substantial equivalence to a legally marketed predicate device. This type of submission focuses on demonstrating that the new device is as safe and effective as an existing, legally marketed device. It does not typically involve the kind of performance studies with explicit acceptance criteria related to AI output, ground truth establishment, or human reader performance as would be seen for AI/ML-based medical devices.
Therefore, many of the requested categories are not applicable to this document. The study described is primarily focused on biocompatibility and comparison of technical characteristics to a predicate device.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity | Conforms to appropriate specifications |
| Mutagenicity | Conforms to appropriate specifications |
| Hemolysis | Conforms to appropriate specifications |
| Acute Systemic Toxicity | Conforms to appropriate specifications |
| Intracutaneous Reactivity | Conforms to appropriate specifications |
| Implantation Tests | Conforms to appropriate specifications |
| Pyrogenicity | Conforms to appropriate specifications |
| Sensitization | Conforms to appropriate specifications |
| Material Equivalence: | |
| Transducer/protector materials identical to blood tubing set components | Yes, "The transducer/protector is composed of materials identical to those contained in blood tubing set components and similar to marketed components." |
| Substantial Equivalence to Predicate Device: | |
| Configuration similar to legally marketed devices | Yes, "The configuration of the subject device kit is similar to legally marketed devices from Medisystems Corporation." |
| Labeling similar to predicate device | Yes, "Labeling for the competitor's devices is similar to the subject device." |
| Intended use similar to predicate device | Yes, "the intended use for the competitors' products is similar to that of the subject device." |
| Labeled as sterile | Yes, "All of the devices are labeled as sterile" |
| Labeled for single use only | Yes, "and for single use only." |
| Restricted to sale by or on the order of a physician | Yes, "The devices are restricted to sale by or on the order of a physician." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for biocompatibility tests. For the comparison to the predicate device, it appears to be a qualitative comparison of device characteristics rather than a quantitative test set with a specific sample size.
- Data Provenance: Not specified, but generally, biocompatibility testing is performed in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This type of information is not relevant to a 510(k) submission primarily focused on material safety and equivalence to a predicate device. Biocompatibility results are typically based on laboratory assay outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This concept is relevant for expert review of medical images or other complex data where ground truth is ambiguous. It does not apply to the described biocompatibility testing or comparison of device characteristics.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a physical medical device, not an AI/ML-based diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Biocompatibility ground truth: Standards for
- Cytotoxicity
- Mutagenicity
- Hemolysis
- Acute Systemic Toxicity
- Intracutaneous Reactivity
- Implantation toxicity (e.g., irritation, inflammation)
- Pyrogenicity
- Sensitization
- Equivalence ground truth: Characteristics of the legally marketed predicate device (Medisystems Corporation ReadySet™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors).
8. The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI/ML system.
9. How the ground truth for the training set was established:
- Not Applicable. This is a physical medical device, not an AI/ML system.
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.